Localized Aggressive PeriodontitisNCT03625414
Tissue Alterations in Aggressive and Chronic Periodontitis
An observational study of Localized Aggressive Periodontitis and Chronic Periodontitis, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Present study intended to compare diseased and healthy sites in chronic and aggressive periodontitis with healthy individuals. The investigators suggest that even unaffected healthy sites of both chronic and aggressive periodontitis patients exhibit subclinical inflammation and tissue destruction with decreased… Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Localized Aggressive Periodontitis, Chronic Periodontitis
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 1 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals, chronic periodontitis patients, and localized aggressive periodontitis patients older than 30 years old and younger than 45 years old were enrolled. The age was specifically chosen because aging changes periodontal and gingival tissues independently of other variables. Any possible factor which might alter connective tissue metabolism were excluded.
Who may be able to join
- Age range from 30 to 45, the existence of at least 20 functioning teeth, no history of smoking, systemical health, no antibiotic use within 6 months, no periodontal therapy within 6 months, no pregnancy or lactation, no drug use, in addition; For healthy individuals, the existence of oral health
- For localized aggressive periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient.
- For chronic periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient.
Who cannot join
- Patients younger than 30 older than 45 years old, the absence of occlusion, drug use, pregnancy/lactation, smoking, previous antibiotic use, previous periodontal therapy, the existence of any systemical disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University Faculty of Dentistry
Tokat Province, 60100
About this study
Official title: Comparison of the Physiologic and Biochemical Alterations in the Healthy and Affected Sites of Chronic and Aggressive Periodontitis Patients
Present study intended to compare diseased and healthy sites in chronic and aggressive periodontitis with healthy individuals. The investigators suggest that even unaffected healthy sites of both chronic and aggressive periodontitis patients exhibit subclinical inflammation and tissue destruction with decreased fibroblast cell counts and increased inflammatory cell counts. Investigators also suggest that a possible mechanism which might play a role in the disease progression might occur via a disbalance between matrix metalloproteinases and their inhibitors, and increased hypoxia in diseased sites.
Read the detailed description
Periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the production of collagen, the quality, and quantity of the connective tissue. The etiology and pathogenesis of chronic periodontitis are mostly revealed however, there are many dark points in the etiopathogenesis of aggressive periodontitis. The existence of periodontal destruction at even one tooth in the mouth increases the risk of further periodontal destruction. However, the incidence of progression of the disease to the unaffected teeth was not demonstrated. Yet, the progression of the disease from diseased sites to healthy sites is likely to occur but no evidence is present comparing healthy and diseased sites of chronic and aggressive periodontitis. Present study aimed to evaluate the histological changes in both diseased and healthy sites in both localized aggressive periodontitis (LAgP) and chronic periodontitis (CP) patients by determining fibroblast and inflammatory cell counts in histologic slides and immunohistochemical staining of enzymes and hypoxia markers in order to better understand the dimensions of this demolition in periodontal disease.
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Gingival biopsies of healthy individuals who had no systemic or oral disease or condition. | |
| Unaffected sites of CP | Chronic periodontitis patients had teeth affected from destruction and some teeth were unaffected. Gingival biopsies of chronic periodontitis patients were taken from sites which were not affected by periodontal destruction. | |
| Affected sites of CP | Chronic periodontitis patients had teeth affected from destruction and some teeth were unaffected. Gingival biopsies of chronic periodontitis patients were taken from sites which were affected by periodontal destruction. | |
| Unaffected sites of LAgP | Like chronic periodontitis, aggressive periodontitis patients had also teeth affected by destruction and some teeth were unaffected. Gingival biopsies of aggressive periodontitis patients were taken from sites which were not affected by the periodontal destruction. | |
| Affected sites of LAgP | Like chronic periodontitis, aggressive periodontitis patients had also teeth affected by destruction and some teeth were unaffected. Gingival biopsies of aggressive periodontitis patients were taken from sites which were affected by the periodontal destruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast and total inflammatory cell counts
Fibroblast and total inflammatory cell counts in the groups were determined in a standardized 1000 micrometer square area with histomorphometric evaluation.
Measured: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after.
Secondary outcomes (1)
Immunohistochemical staining
Expressions of matrix metalloproteinase 8 and tissue inhibitor, hypoxia inducible factor-1alpha and vascular endothelial growth factor were evaluated in histological slides.
Measured: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Feb 2017
- Primary completion1 Feb 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Aggressive PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Balci Yuce, Tokat Gaziosmanpasa University
- Investigators
- HATİCE BALCI YÜCE, PhD, Principal investigator, Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625414
- Sponsor's protocol ID
- balciyuce
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Physiologic and Biochemical Alterations in the Healthy and Affected Sites of Chronic and Aggressive Periodontitis Patients
- ClinicalTrials.gov ID
- NCT03625414
- Acronym / sponsor ID
- balciyuce
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Present study intended to compare diseased and healthy sites in chronic and aggressive periodontitis with healthy individuals. The investigators suggest that even unaffected healthy sites of both chronic and aggressive periodontitis patients exhibit subclinical inflammation and tissue destruction with decreased fibroblast cell counts and increased inflammatory cell counts. Investigators also suggest that a possible mechanism which might play a role in the disease progression might occur via a disbalance between matrix metalloproteinases and their inhibitors, and increased hypoxia in diseased sites.
Detailed description
Periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the production of collagen, the quality, and quantity of the connective tissue. The etiology and pathogenesis of chronic periodontitis are mostly revealed however, there are many dark points in the etiopathogenesis of aggressive periodontitis. The existence of periodontal destruction at even one tooth in the mouth increases the risk of further periodontal destruction. However, the incidence of progression of the disease to the unaffected teeth was not demonstrated. Yet, the progression of the disease from diseased sites to healthy sites is likely to occur but no evidence is present comparing healthy and diseased sites of chronic and aggressive periodontitis. Present study aimed to evaluate the histological changes in both diseased and healthy sites in both localized aggressive periodontitis (LAgP) and chronic periodontitis (CP) patients by determining fibroblast and inflammatory cell counts in histologic slides and immunohistochemical staining of enzymes and hypoxia markers in order to better understand the dimensions of this demolition in periodontal disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | –Gingival biopsies of healthy individuals who had no systemic or oral disease or condition. |
| Unaffected sites of CP | – | –Chronic periodontitis patients had teeth affected from destruction and some teeth were unaffected. Gingival biopsies of chronic periodontitis patients were taken from sites which were not affected by periodontal destruction. |
| Affected sites of CP | – | –Chronic periodontitis patients had teeth affected from destruction and some teeth were unaffected. Gingival biopsies of chronic periodontitis patients were taken from sites which were affected by periodontal destruction. |
| Unaffected sites of LAgP | – | –Like chronic periodontitis, aggressive periodontitis patients had also teeth affected by destruction and some teeth were unaffected. Gingival biopsies of aggressive periodontitis patients were taken from sites which were not affected by the periodontal destruction. |
| Affected sites of LAgP | – | –Like chronic periodontitis, aggressive periodontitis patients had also teeth affected by destruction and some teeth were unaffected. Gingival biopsies of aggressive periodontitis patients were taken from sites which were affected by the periodontal destruction. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals, chronic periodontitis patients, and localized aggressive periodontitis patients older than 30 years old and younger than 45 years old were enrolled. The age was specifically chosen because aging changes periodontal and gingival tissues independently of other variables. Any possible factor which might alter connective tissue metabolism were excluded.
Key inclusion criteria (3 listed)
- Age range from 30 to 45, the existence of at least 20 functioning teeth, no history of smoking, systemical health, no antibiotic use within 6 months, no periodontal therapy within 6 months, no pregnancy or lactation, no drug use, in addition; For healthy individuals, the existence of oral health
- For localized aggressive periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient.
- For chronic periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient.
Key exclusion criteria (1 listed)
- Patients younger than 30 older than 45 years old, the absence of occlusion, drug use, pregnancy/lactation, smoking, previous antibiotic use, previous periodontal therapy, the existence of any systemical disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fibroblast and total inflammatory cell counts
Time frame: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after.
Fibroblast and total inflammatory cell counts in the groups were determined in a standardized 1000 micrometer square area with histomorphometric evaluation.
1 secondary outcome
Immunohistochemical staining
Time frame: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HATİCE BALCI YÜCE, PhD principal investigator
Gaziosmanpasa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Localized Aggressive Periodontitis and Chronic Periodontitis, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibroblast and total inflammatory cell counts (time frame: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.